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Comparative Efficacy of Omeprazole plus Mosapride Combination Therapy versus Omeprazole Monotherapy in Patients with Proton Pump Inhibitor-Refractory Gastroesophageal Reflux Disease: a randomized controlled trial

Comparative Efficacy of Omeprazole plus Mosapride Combination Therapy versus Omeprazole Monotherapy in Patients with Proton Pump Inhibitor-Refractory Gastroesophageal Reflux Disease: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190418003
Enrollment
Unknown
Registered
2019-04-18
Start date
2016-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

proton pump inhibitor refractory gastroesophageal reflux disease mosapride

Interventions

omeprazole 20 mg once daily plus mosapride 5 mg thrice daily for 4 weeks ,omeprazole 20 mg once daily plus placebo thrice daily for 4 weeks
Experimental Drug,Active Comparator Drug
omeprazole plus mosapride combination therapy,omeprazole monotherapy

Sponsors

Rajavithi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: the patients who experienced a symptom of heartburn and/or regurgitation more than twice weekly unresponsive to at least 8 weeks of a standard dose of proton pump inhibitor, defined by having the frequency scale for symptoms of gastroesophageal reflux disease total score of eight points or more

Exclusion criteria

Exclusion criteria: (i) who had a previous history of esophageal or gastrointestinal surgery except appendectomy and cholecystectomy (ii) who had severe cardiac or pulmonary disease, renal failure, liver cirrhosis and severe systemic illness (iii) who had an active Helicobacter pylori infection, determined by both the rapid urease test and histological identification, or upper gastrointestinal diseases such as malignancy or peptic ulcers (iv) who was in a state of pregnancy or lactating woman (v) who were hypersensitivity or allergy to mosapride or omeprazole

Design outcomes

Primary

MeasureTime frame
gastroesophageal reflux symptom relief at the end of the intervention the frequency scale for symptoms of gastroesophageal reflux disease

Secondary

MeasureTime frame
number of symptoms free day within 4 weeks of the study period patient reported outcome using a diary book

Countries

Thailand

Contacts

Public ContactApichet Sirinawasatien

Rajavithi Hospital

sui_apichet@hotmail.com081-6862151

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026